TopChem operates to the highest international Quality, Safety and Environmental standards.
Product Development
The evolution of the chemical synthesis of an API from laboratory to manufacturing scale is a complex process, which is both specialised and intensive. Our experience and expertise in this area means that TopChem can offer our customers a rapid custom development of commercial supply of generic or specialty pharmaceutical products.
All our current products have been developed in response to customer demand, filling the gap in the market for niche, low volume APIs and related cGMP products.
We have an extensive and proven track record in designing new syntheses, combining high creativity with a sound commercial focus, and developing and validating these processes up to full scale pharmaceutical production. Our Products page shows the range of products we have developed. We fully respect third party intellectual property (IP) and develop non-infringing process technology. We have successfully obtained patent protection on a number of our products.
Recent Projects
- Developed a proprietary polymer substrate for a slow-release drug delivery device.
- Developed a novel purification method to upgrade a third-party API process to reduce related substances below ICH limits.
Custom Synthesis
Building on our experience of API development we can supply reference standard impurities, metabolites and related research materials. Using our supply chain network we generally source advanced intermediates to facilitate rapid and cost effective supply of these materials
